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Regulation of US and EU Biologics

This course examines the special characteristics of biologic products and the challenges associated with their development in the US and EU. It also introduces various aspects specific to their manufacturing, nonclinical and clinical development, and some global regulatory considerations that add further complexity (e.g., e-Submission). Each lesson includes references to regulatory source documents, as well as to international guidance documents that will provide further knowledge and understanding of biologic products.

Course Details

 At A Glance
  • Target Audience: This course is beneficial for regulatory professionals and those interested in understanding the basics of US and EU biologics regulations.
  • Learning Level: Basic
  • Total Length of Course: 5 Hours
  • RAC Points: 5
  • Formats: Web and iPad
  • Cost: Member $425; Nonmember $595
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 Learning Objectives

Upon completion of this course, participants should be able to:

  • Define the characteristics of biologics and biotechnology-derived products
  • Outline the regulatory evolution of current biologics regulations
  • Explain differences between large- and small-molecule drugs
  • Identify the challenges of developing biologics for market
  • Discuss the status, difficulties and barriers of follow-on biologics/biosimilars
 Lesson Titles
  • Lesson 1: Overview of Biologics
  • Lesson 2: Overview of the Regulation of US Biologics
  • Lesson 3: Overview of EU Considerations for Biologics
  • Lesson 4: Regulatory Considerations for Lifecycle Management
  • Lesson 5: Regulatory Procedures
  • Lesson 6: Global Considerations for Biologics
  • Lesson 7: Compliance and Postmarketing for Approved Biologics
  • Lesson 8: Importing Biologics Into the US and the EU
 Registration Options

This course is available for purchase as follows: